Development of a Tool to Assess the Level of Implementing the European Standards of Care for Newborn HealthNCT06379828
Self-assessment Tool for Implementing the ESCNH
An observational study of Development of a Tool to Assess the Level of Implementing the European Standards of Care for Newborn Health and Testing of the Developed Self-assessment Tool in European Hospitals, run by Global Foundation for the Care of Newborn Infants at 1 site in Germany.
Trial summary
This study aims to develop a tool for hospitals to self-assess the implementation of the European Standards of Care for Newborn Health (ESCNH), standards defining best-practice procedures for neonatal care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Development of a Tool to Assess the Level of Implementing the European Standards of Care for Newborn Health, Testing of the Developed Self-assessment Tool in European Hospitals, Self-Assessment
- What is being tested?
- Please note that this is an observational study; not applicable
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 3 Jun 2024to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The PEG consists of 8 renowned experts of multidisciplinary professions: neonatologists, a (neonatal) nurses, an obstetrician, a parent representative, a public health expert, and a statistician and is completed by members of the EFCNI study team. The eDelphi panels will consist of experts from various European countries from the following fields: neonatology, midwifery, (neonatal) care, obstetrics, parent representing institutions, psychology, and physiotherapy. Participants for the pilot-testing will be healthcare professionals with varying professional backgrounds in pilot hospitals across Europe.
Who may be able to join
None listed.
Who cannot join
- provide insufficient proficiency of English for the eDelphi questionnaires or the languages of the self-assessment tool in the pilot testing, or
- have a professional background that is not related to the ESCNH / individuals that are not parent representatives or representatives of caregiver of infants who received special/intensive care.
- primarily work in the industry.
Trial locations and contacts
1 site in 1 country.
Germany1 site
European Foundation for the Care of Newborn Infants (EFCNI)
Munich, Bavaria, 81379
Isabel Geiger, Dr., 0049 89 89 0 83 26-0, isabel.geiger@efcni.org
Julia Hoffmann, Dr., julia.hoffmann@efcni.org
About this study
Official title: Hospital Self-assessment Tool for the Implementation of the European Standards of Care for Newborn Health (ESCNH)
This study aims to develop a tool for hospitals to self-assess the implementation of the European Standards of Care for Newborn Health (ESCNH), standards defining best-practice procedures for neonatal care. The tool shall support healthcare professionals across Europe to measure the level of implementation of the ESCNH, to identify variations in care delivery, and ultimately to improve neonatal care. To achieve this, healthcare professionals from all relevant backgrounds and parent representatives will be invited to take part in an electronic Delphi consensus approach. A subsequent pilot-testing among at least 10 hospitals across Europe will refine the developed tool, indicate potential errors, ensure user-friendliness, and improve the applicability.
Read the detailed description
This project aims to develop a uniformly applicable self-assessment tool in different languages with the overall goal to support care providers across Europe to measure the level of implementation of the ESCNH, to pinpoint possible inhibitors, and ultimately to increase the extent of implementation. Covering the great variety of standards in one hands-on and easy-to-use self-assessment tool requires prioritising the most important components. This has to be approached in a systematic and scientific manner. For this purpose, a two-round electronic (e) Delphi survey will be conducted followed by an expert workshop. The aim of the two-stage eDelphi process is to lay a solid ground for the self-assessment tool. Prior to the eDelphi rounds, members of the study team together with the Project Expert Group (PEG) will condense and prioritise the ESCNH into one online questionnaire and thereby elaborate the first framework of the self-assessment tool. Next to participant-related information such as profession or country of employment, the questionnaire will cover specific aspects of the eleven major topics of the ESCNH namely: Birth and transfer, medical care and clinical practice, care procedures, infant- and family-centred developmental care, neonatal intensive care unit (NICU) design, nutrition, ethical decision-making and palliative care, follow-up and continuing care, patient safety and hygiene practice, data collection and documentation, education and training. The questionnaire will subsequently, in the first eDelphi round, be evaluated by the eDelphi panel. The panel consist of approximately 100 healthcare professionals from various disciplines related to neonatal care as well as parent representatives. In the first eDelphi round, panellists will appraise the relevance of included content, the wording of questions as well as the prioritisation of content to be included in the self-assessment tool. This will be enabled through a predefined evaluation scheme as well as free-text fields. Based on feedback from panellists, the preliminary self-assessment tool will be adapted by adding additional information, removing unnecessary items and re-wording if necessary. In the subsequent (second) eDelphi round, the same panellists will receive qualitative and quantitative information on the adaptation of the first version and will have again the option to evaluate the adapted questionnaire. Remaining discrepancies will be discussed in a final consensus workshop. For this purpose, 20-30 panellists will be selected based on their level of experience and invited for participation. The result of the workshop will be the agreed-upon content for the self-assessment tool. Except for the workshop, data collection during the eDelphi rounds will be anonymous.
To ensure applicability, the self-assessment tool will be pilot tested in European hospitals. For this purpose, the self-assessment tool will be translated into 5 languages (German, French, Italian, Swedish, Portuguese, and Spanish). For the pilot-testing, healthcare professionals in 10 pilot hospitals across Europe will be invited to evaluate the self-assessment tool. Feedback of the pilot-testing will be discussed with the PEG and adapted accordingly.
- Conditions
- Development of a Tool to Assess the Level of Implementing the European Standards of Care for Newborn Health, Testing of the Developed Self-assessment Tool in European Hospitals, Self-Assessment
- Being tested
- Please note that this is an observational study; not applicable
- Keywords
- ESCNH, EFCNI, eDlephi method, Pilot-testing, Implementation, Self-assessment, Tool, Neonatal care standards
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Please note that this is an observational study; not applicableOther
Please note that this is an observational study; not applicable
| Study group | Role | What they receive |
|---|---|---|
| eDelphi panel/participants | The eDelphi panels will consist of approximately 100 healthcare professionals from various European countries from the following fields: neonatology, midwifery, (neonatal) care, obstetrics, parent representing institutions, psychology, and physiotherapy. 20-30 of them will be invited for a final consensus workshop. Receives: Other: Please note that this is an observational study; not applicable | |
| Pilot hospitals | 10 hospitals with neonatal units from Germany, UK, France, Italy, Sweden, Portugal, and Spain. Receives: Other: Please note that this is an observational study; not applicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Online self-assessment tool (including statements and questions)
Within a two-round eDelphi survey, the eDelphi panel will critically appraise the first template of the self-assessment tool. If required (indicated by ≥ 80% of participants) additional items will be added or unnecessary items will be removed. Remaining discrepancies will be discussed in a final consensus workshop and the questionnaire will be adapted based on consensus gathered within the workshop. The resulting questionnaire will be the first version of the self-assessment tool, which will be evaluated during and adapted after a pilot-testing phase.
Measured: 15.06.2024 - 15.07.2025
Secondary outcomes (7)
Response rates
Number of participants completing the first and second eDelphi round, number of hospitals joining the pilot-testing phase
Measured: 15.10.2024 - 30.06.2025
Demographics and characteristics
A summary of demographic information and the participants characteristics will be presented
Measured: 15.10.2024 - 30.06.2025
User-friendliness score of the self-assessment tool
Time taken to fill in, illustration on screen, understandability
Measured: 15.10.2024 - 30.06.2025
Applicability score of the formulation of the questions
Evaluation data on formulation of the questions and understandability
Measured: 15.10.2024 - 30.06.2025
Qualitative feedback on illustration of output
Evaluation data on illustration of questionnaire on the screen
Measured: 15.10.2024 - 30.06.2025
Appraisal on the utilisation of the self-assessment tool
Evaluation data on the utilisation of the self-assessment tool
Measured: 15.10.2024 - 30.06.2025
Scalability of the self-assessment tool and dissemination
Evaluation data on the usage and outreach
Measured: 15.10.2024 - 30.06.2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start3 Jun 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Development of a Tool to Assess the Level of Implementing the European Standards of Care for Newborn HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global Foundation for the Care of Newborn Infants
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Zimmermann, Global Foundation for the Care of Newborn Infants
- Investigators
- Silke Mader, Study director, Global Foundation for the Care of Newborn InfantsJulia Hoffmann, Dr., Study director, Global Foundation for the Care of Newborn Infants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379828
- Sponsor's protocol ID
- 2024-0140
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lindacher V, Altebaeumer P, Marlow N, Matthaeus V, Straszewski IN, Thiele N, Pfeil JM, Zimmermann LJI, Mader S; European Standards of Care for Newborn Health project members. European Standards of Care for Newborn Health-A project protocol. Acta Paediatr. 2021 May;110(5):1433-1438. doi: 10.1111/apa.15712. Epub 2020 Dec 22.
PubMed 33290600Hoffmann J, Lehmann S, Ancora G, Hummler H, Lack N, Schlembach D, Schouten E, Simonelli I, Thernstrom Blomqvist Y, Vavouraki E, Webbe J, Zimmermann LJI, Mader S, Geiger I. Study protocol for the development and pilot-testing of a Self-assessment tool for the implementation of the European Standards of Care for Newborn Health (ESCNH). BMJ Paediatr Open. 2025 Jan 20;9(1):e003008. doi: 10.1136/bmjpo-2024-003008.
PubMed 39837587
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital Self-assessment Tool for the Implementation of the European Standards of Care for Newborn Health (ESCNH)
- ClinicalTrials.gov ID
- NCT06379828
- Acronym / sponsor ID
- 2024-0140
- Conditions
- Development of a Tool to Assess the Level of Implementing the European Standards of Care for Newborn Health, Testing of the Developed Self-assessment Tool in European Hospitals, Self-Assessment
- Keywords
- ESCNH, EFCNI, eDlephi method, Pilot-testing, Implementation, Self-assessment, Tool, Neonatal care standards
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Global Foundation for the Care of Newborn InfantsUniversity, hospital or other
- Study start
- 3 Jun 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop a tool for hospitals to self-assess the implementation of the European Standards of Care for Newborn Health (ESCNH), standards defining best-practice procedures for neonatal care. The tool shall support healthcare professionals across Europe to measure the level of implementation of the ESCNH, to identify variations in care delivery, and ultimately to improve neonatal care. To achieve this, healthcare professionals from all relevant backgrounds and parent representatives will be invited to take part in an electronic Delphi consensus approach. A subsequent pilot-testing among at least 10 hospitals across Europe will refine the developed tool, indicate potential errors, ensure user-friendliness, and improve the applicability.
Detailed description
This project aims to develop a uniformly applicable self-assessment tool in different languages with the overall goal to support care providers across Europe to measure the level of implementation of the ESCNH, to pinpoint possible inhibitors, and ultimately to increase the extent of implementation. Covering the great variety of standards in one hands-on and easy-to-use self-assessment tool requires prioritising the most important components. This has to be approached in a systematic and scientific manner. For this purpose, a two-round electronic (e) Delphi survey will be conducted followed by an expert workshop. The aim of the two-stage eDelphi process is to lay a solid ground for the self-assessment tool. Prior to the eDelphi rounds, members of the study team together with the Project Expert Group (PEG) will condense and prioritise the ESCNH into one online questionnaire and thereby elaborate the first framework of the self-assessment tool. Next to participant-related information such as profession or country of employment, the questionnaire will cover specific aspects of the eleven major topics of the ESCNH namely: Birth and transfer, medical care and clinical practice, care procedures, infant- and family-centred developmental care, neonatal intensive care unit (NICU) design, nutrition, ethical decision-making and palliative care, follow-up and continuing care, patient safety and hygiene practice, data collection and documentation, education and training. The questionnaire will subsequently, in the first eDelphi round, be evaluated by the eDelphi panel. The panel consist of approximately 100 healthcare professionals from various disciplines related to neonatal care as well as parent representatives. In the first eDelphi round, panellists will appraise the relevance of included content, the wording of questions as well as the prioritisation of content to be included in the self-assessment tool. This will be enabled through a predefined evaluation scheme as well as free-text fields. Based on feedback from panellists, the preliminary self-assessment tool will be adapted by adding additional information, removing unnecessary items and re-wording if necessary. In the subsequent (second) eDelphi round, the same panellists will receive qualitative and quantitative information on the adaptation of the first version and will have again the option to evaluate the adapted questionnaire. Remaining discrepancies will be discussed in a final consensus workshop. For this purpose, 20-30 panellists will be selected based on their level of experience and invited for participation. The result of the workshop will be the agreed-upon content for the self-assessment tool. Except for the workshop, data collection during the eDelphi rounds will be anonymous.
To ensure applicability, the self-assessment tool will be pilot tested in European hospitals. For this purpose, the self-assessment tool will be translated into 5 languages (German, French, Italian, Swedish, Portuguese, and Spanish). For the pilot-testing, healthcare professionals in 10 pilot hospitals across Europe will be invited to evaluate the self-assessment tool. Feedback of the pilot-testing will be discussed with the PEG and adapted accordingly.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eDelphi panel/participants | – | Other: Please note that this is an observational study; not applicableThe eDelphi panels will consist of approximately 100 healthcare professionals from various European countries from the following fields: neonatology, midwifery, (neonatal) care, obstetrics, parent representing institutions, psychology, and physiotherapy. 20-30 of them will be invited for a final consensus workshop. |
| Pilot hospitals | – | Other: Please note that this is an observational study; not applicable10 hospitals with neonatal units from Germany, UK, France, Italy, Sweden, Portugal, and Spain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The PEG consists of 8 renowned experts of multidisciplinary professions: neonatologists, a (neonatal) nurses, an obstetrician, a parent representative, a public health expert, and a statistician and is completed by members of the EFCNI study team. The eDelphi panels will consist of experts from various European countries from the following fields: neonatology, midwifery, (neonatal) care, obstetrics, parent representing institutions, psychology, and physiotherapy. Participants for the pilot-testing will be healthcare professionals with varying professional backgrounds in pilot hospitals across Europe.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- provide insufficient proficiency of English for the eDelphi questionnaires or the languages of the self-assessment tool in the pilot testing, or
- have a professional background that is not related to the ESCNH / individuals that are not parent representatives or representatives of caregiver of infants who received special/intensive care.
- primarily work in the industry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Please note that this is an observational study; not applicablePlease note that this is an observational study; not applicable | Other | Pilot hospitals, eDelphi panel/participants |
Primary outcome
Online self-assessment tool (including statements and questions)
Time frame: 15.06.2024 - 15.07.2025
Within a two-round eDelphi survey, the eDelphi panel will critically appraise the first template of the self-assessment tool. If required (indicated by ≥ 80% of participants) additional items will be added or unnecessary items will be removed. Remaining discrepancies will be discussed in a final consensus workshop and the questionnaire will be adapted based on consensus gathered within the workshop. The resulting questionnaire will be the first version of the self-assessment tool, which will be evaluated during and adapted after a pilot-testing phase.
7 secondary outcomes
Response rates
Time frame: 15.10.2024 - 30.06.2025
Demographics and characteristics
Time frame: 15.10.2024 - 30.06.2025
User-friendliness score of the self-assessment tool
Time frame: 15.10.2024 - 30.06.2025
Applicability score of the formulation of the questions
Time frame: 15.10.2024 - 30.06.2025
Qualitative feedback on illustration of output
Time frame: 15.10.2024 - 30.06.2025
Appraisal on the utilisation of the self-assessment tool
Time frame: 15.10.2024 - 30.06.2025
Scalability of the self-assessment tool and dissemination
Time frame: 15.10.2024 - 30.06.2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Background: PubMed 33290600Lindacher V, Altebaeumer P, Marlow N, Matthaeus V, Straszewski IN, Thiele N, Pfeil JM, Zimmermann LJI, Mader S; European Standards of Care for Newborn Health project members. European Standards of Care for Newborn Health-A project protocol. Acta Paediatr. 2021 May;110(5):1433-1438. doi: 10.1111/apa.15712. Epub 2020 Dec 22.
- Derived from this study: PubMed 39837587Hoffmann J, Lehmann S, Ancora G, Hummler H, Lack N, Schlembach D, Schouten E, Simonelli I, Thernstrom Blomqvist Y, Vavouraki E, Webbe J, Zimmermann LJI, Mader S, Geiger I. Study protocol for the development and pilot-testing of a Self-assessment tool for the implementation of the European Standards of Care for Newborn Health (ESCNH). BMJ Paediatr Open. 2025 Jan 20;9(1):e003008. doi: 10.1136/bmjpo-2024-003008.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silke Mader study director
Global Foundation for the Care of Newborn Infants
Julia Hoffmann, Dr. study director
Global Foundation for the Care of Newborn Infants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Development of a Tool to Assess the Level of Implementing the European Standards of Care for Newborn Health and Testing of the Developed Self-assessment Tool in European Hospitals, run by Global Foundation for the Care of Newborn Infants at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabel Geiger, Dr. (+49 (0) 89 89 0 83 26-0, isabel.geiger@efcni.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Online self-assessment tool (including statements and questions) (time frame: 15.06.2024 - 15.07.2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06379828, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.